Cleared Traditional

K133781 - DECLIPSESPECT LAPAROSCOPY (FDA 510(k) Clearance)

Class I Radiology device.

K133781 · Surgiceye GmbH · Radiology device
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Apr 2014
Decision
120d
Days
Class 1
Risk

K133781 is an FDA 510(k) clearance for the DECLIPSESPECT LAPAROSCOPY. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Surgiceye GmbH (Munich, Bavaria, DE). The FDA issued a Cleared decision on April 11, 2014 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgiceye GmbH devices

Submission Details

510(k) Number K133781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date April 11, 2014
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 107d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.